Therapeutic Effects of Compound Zhenzhu Tiaozhi Capsules in NAFLD

The First Affiliated Hospital of Guangdong Pharmaceutical University

Status: Unknown

Conditions: Nonalcoholic Fatty Liver Disease

Treatments: Drug: Compound Zhenzhu Tiaozhi capsule; Drug: Simvastatin; Dietary Supplement: TLC; Drug: metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03375580

U1111-1201-8245

Details and patient eligibility

About

This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions.

Full description

This is a randomised clinical trial which aims to evaluate the efficacy of Compound Zhenzhu Tiaozhi capsules in the treatment of NAFLD and analyze the relationship between improvement in NAFLD parameters and changes in intestinal functions. In this study, the investigators will (1)evaluate the relationship between the function of intestinal mucosal barrier, SIBO, and NAFLD;(2)assess the effects of Compound Zhenzhu Tiaozhi capsules on intrahepatic fat content, hepatic noninvasive score, liver biochemical parameters, blood lipid, and insulin resistance. To evaluate the therapeutic effects of Compound Zhenzhu Tiaozhi capsules on the treatment of NAFLD, and determine whether the risk stratification of atherosclerotic cardiovascular disease (ASCVD) and quality of life (using the 36-Item Short Form Health Survey [SF-36]) can be improved in NAFLD patients with Compound Zhenzhu Tiaozhi capsules;(3) compare the therapeutic effects of Compound Zhenzhu Tiaozhi capsules with conventional medications in the treatment of NAFLD, and to compare their efficacies in improving the risk stratification of ASCVD and quality of life, as assessed by the SF-36; (4) analyze the relationship of Compound Zhenzhu Tiaozhi capsules in improving NAFLD and parameters related to the function of the intestinal mucosal barrier and SIBO.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

clinical diagnosis of simple steatosis or NASH 18 to 75 years old serum alanine transaminase (ALT)≤2 times the upper limit of normal

Exclusion criteria

other chronic liver diseases serious complications in other organs malignant tumors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 4 patient groups, including a placebo group

TLC group

Placebo Comparator group

Description:

transform life custom (TLC) group

Treatment:

Dietary Supplement: TLC

TLC + metformin group

Active Comparator group

Description:

transform life custom (TLC) combined with 0.5g metformin, PO tid

Treatment:

Dietary Supplement: TLC

Drug: metformin

TLC + CZT capsules group

Experimental group

Description:

transform life custom (TLC) combined with 2.52 Compound Zhenzhu Tiaozhi capsules (four tablets), PO tid

Treatment:

Dietary Supplement: TLC

Drug: Compound Zhenzhu Tiaozhi capsule

TLC + simvastatin group

Active Comparator group

Description:

transform life custom (TLC) combined with 20mg simvastatin, PO qn

Treatment:

Dietary Supplement: TLC

Drug: Simvastatin